European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on May 04, 2022, by updating the below documents in Module 02- High-level overview of CTIS workspaces and common system functionalities and Module 03- User access management:
- Clinical Trials Information System (CTIS) common features – Module 02 (v1.3): Updated the name of Module 02 in the title of the document
- Quick guide: User access management – Module 03 (v1.3): Updated by adding more information on how to search for an organization and submit a request to create an organization in CTIS
- Quick guide: How to use the Organisation Management Service (OMS) – Module 03 (v1.1): It guides searching for an organization in CTIS. It also provides steps to submit a request to create an organization and to update the information of an existing organization along with CTIS insights for each section
- FAQs: User access management – Module 03 (v1.3): Updated by adding two new sections – ‘Login and Landing page’ and ‘Organizations’. It provides answers to questions related to login into a secured workspace, access to credentials of this workspace, the process if the user forgets the password, validation of organizations, organization ID, and if the ethics committee needs to register as an organization. The questions and answers that are added or revised in this version are –
- Section 1.1: This section was revised by adding information for EMA account management
- Section 1.2: This section was newly added providing information if users with EudraLink account need to re-register to get the access to CTIS
- Section 1.3: This section was newly added providing information on how to close an existing account
- Section 1.4: This section was revised by adding a link for a self-registration guide for reference
- Section 3.3: This section was revised by updating the information on how users can update their employer’s information
- Section 4.8: This section was newly added providing information if one or more roles can be assigned to users